Spots Global Cancer Trial Database for Dexamethasone vs Placebo in the Prophylaxis of Radiation-Induced Pain Flare Following Palliative Radiotherapy for Bone Metastases
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Trial Identification
Brief Title: Dexamethasone vs Placebo in the Prophylaxis of Radiation-Induced Pain Flare Following Palliative Radiotherapy for Bone Metastases
Official Title: A Randomized Phase III Double-Blind Study of Dexamethasone Versus Placebo in the Prophylaxis of Radiation-Induced Pain Flare Following Palliative Radiotherapy for Bone Metastases
Study ID: NCT01248585
Conditions
Study Description
Brief Summary: This research is being done because is is not known if dexamethasone can prevent pain flare (their pain temporarily gets worse before it gets better) caused by the radiation used to treat painful bone metastases. Using dexamethasone to prevent pain like this has been studied in a few people and seems promising, but it is not clear if it can decrease the pain or prevent the pain flare before it happens.
Detailed Description: Previous research has shown that for patients who receive radiation therapy to treat their painful bone metastases, about 2 out of every 5 patients (about 40%) experience pain flare. The purpose of this study is to find out whether pain flare is prevented by receiving 8mg dexamethasone at least one hour prior to radiotherapy and once daily for the following 4 days. To do this, half of the patients in this study will get dexamethasone and the other half will receive a placebo (a substance that does not do anything). Using a placebo is the best way to see if a new therapy is effective and to clearly see the potential side effects and impact on quality of life.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
BCCA - Abbotsford Centre, Abbotsford, British Columbia, Canada
BCCA - Vancouver Cancer Centre, Vancouver, British Columbia, Canada
BCCA - Vancouver Island Cancer Centre, Victoria, British Columbia, Canada
CancerCare Manitoba, Winnipeg, Manitoba, Canada
The Vitalite Health Network - Dr. Leon Richard, Moncton, New Brunswick, Canada
Royal Victoria Regional Health Centre, Barrie, Ontario, Canada
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston, Kingston, Ontario, Canada
Grand River Regional Cancer Centre, Kitchener, Ontario, Canada
London Regional Cancer Program, London, Ontario, Canada
Stronach Regional Health Centre at Southlake, Newmarket, Ontario, Canada
Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
Odette Cancer Centre, Toronto, Ontario, Canada
Univ. Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada
Hopital Maisonneuve-Rosemont, Montreal, Quebec, Canada
CHUM - Hopital Notre-Dame, Montreal, Quebec, Canada
CHUQ-Pavillon Hotel-Dieu de Quebec, Quebec City, Quebec, Canada
Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec, Canada
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
Contact Details
Name: Edward LW Chow
Affiliation: Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto ON
Role: STUDY_CHAIR
Name: Carlo De Angelis
Affiliation: Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto ON
Role: STUDY_CHAIR
Name: Alysa Fairchild
Affiliation: Cross Cancer Institute, Edmonton AB
Role: STUDY_CHAIR
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